Bristol-Myers Squibb GmbH & Co.KG aA

UFT new oral cancer medicine for advanced colorectal cancer recommended for approval in Europe

Brussels, Belgium (ots-PRNewswire) - Bristol-Myers Squibb Company (NYSE:BMY) today announced that UFTÆ (tegafur/uracil) capsules has been recommended for approval through the Mutual Recognition Procedure by fourteen Member States of the European Union plus Norway and Iceland. The mutual recognition allows Bristol-Myers Squibb to prepare to market UFT, in combination with calcium folinate(1) (Leucovorin, LV) for the first-line treatment of metastatic colorectal cancer. "The positive recommendation of UFT represents a significant step forward in providing an effective, well-tolerated oral chemotherapy choice for patients with advanced colorectal cancer," said Professor James Carmichael, JB Cochrane Cancer Research Campaign Professor of Clinical Oncology, City Hospital, Nottingham, U.K., a lead investigator of the European UFT Phase III clinical trials. "Traditionally, these patients have been restricted to receiving intravenous treatment; we can now in addition offer a safe, effective oral chemotherapy option to these patients." This approval was based on results of two large, international, multi-center Phase III clinical trials performed at 132 sites across Europe, the U.S., Canada, Australia and Israel (study 011 and study 012). Study 011, which included 816 patients, is the largest registrational trial ever conducted for the treatment of advanced colorectal cancer. In patients with advanced colorectal cancer the key goal of treatment is to prolong survival. An analysis of the pooled survival results for the two studies (1,196 patients) shows that patients receiving UFT/LV had similar survival to those receiving IV 5-FU/LV (12.4 months for UFT/LV vs. 12.6 months for IV 5-FU/LV). Importantly, patients in the oral UFT/LV groups in both studies experienced significantly fewer side effects than those in the standard treatment group. In study 011, for example, the incidences of severe neutropenia (1% vs 56%), febrile neutropenia (0% vs 13%) and severe stomatitis (1% vs 19%,) were all less in patients treated with UFT/LV. Even the most frequently reported side effect seen in the UFT/LV group - diarrhea (of any grade) - was experienced less frequently by patients receiving UFT/LV compared to those receiving IV 5-FU/LV. "We are truly excited to be able to offer doctors and their patients UFT - a new oral chemotherapy that is not only safe and effective, but also convenient for patients," said Dr. Martin Birkhofer, Executive Director of Oncology Clinical Research Europe, Bristol-Myers Squibb Company. "Bringing UFT to doctors and their patients is only the beginning; we are committed to continuing research on UFT in combination with Leucovorin in colorectal and other cancers, as well as exploring its use with other cancer therapies, in order to discover this new medicine's full range of benefits for patients." Colorectal cancer is the third most common cancer worldwide. There are approximately 200,000 recorded cases and 110,000 deaths in the EU each year. Chemotherapy is the standard treatment for patients that present with metastatic colorectal cancer. Bristol-Myers Squibb is working closely with each EU member state in order to obtain implementation of mutual recognition to market UFT in each of those countries. In Germany and other European countries where UFT has not yet been approved, Bristol-Myers Squibb is working with the local regulatory authorities for subsequent approvals. UFT is currently under review with the U.S. Food and Drug Administration (FDA). Bristol-Myers Squibb licensed UFT capsules in 1995 from Taiho Pharmaceutical Company Limited in Japan. Bristol-Myers Squibb has exclusive rights to market UFT in all countries around the world, except for Japan. Bristol-Myers Squibb is a diversified global health and personal care company whose mission is to extend and enhance human life. The world leader in oncology, Bristol-Myers Squibb is deeply committed to cancer research, clinical development and patient care. Visit Bristol-Myers Squibb on the World Wide Web at Note: The Reference Member State (RMS) for the Mutual Recognition Procedure (MRP) in the EU was Spain. The EU Concerned Member States (CMS) covered in the UFT mutual recognition are Austria, Belgium, Denmark,(2) Finland, France, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Sweden, U.K.(3) References: 1. Calcium Folinate is also known as Leucovorin. 2,3. The UFT tradename is registered, but not yet approved for use in Denmark and the U.K. ots Original Text Service: Bristol-Myers Squibb Internet: Contact: Caroline Almeida, Europe Tel: +32 2 352 7217 Mobile: +32 75 85 95 13 Original-Content von: Bristol-Myers Squibb GmbH & Co.KG aA, übermittelt durch news aktuell

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